Sodium Bicarbonate in Intra-dialytic Hypertension in Chronic Hemodialysis Patients

NCT ID: NCT07231900

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2027-12-01

Brief Summary

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The study is designed to diminish intra-dialytic hypertension in chrnic hemodialysis patients suffering from metabolic acidosis (low bicarbonate levels). The intervention is a tab of 500 mg sodium bicarbonate twice a day for one month, vs. placebo.

Detailed Description

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Conditions

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Hypertension in Dialysis Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sodium bicarbonate

PO Sodium bicarbonate 500mg X2/day

Group Type EXPERIMENTAL

Sodium Bicarbonate (NaHCO3)

Intervention Type DRUG

Prescribing Sodium Bicaronate for intra-dualytic hypertension

Placebo

1 tab X2/day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tab X 2/day

Interventions

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Sodium Bicarbonate (NaHCO3)

Prescribing Sodium Bicaronate for intra-dualytic hypertension

Intervention Type DRUG

Placebo

1 tab X 2/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic hemodialysis patient \> 3 months
* 3 dialysis per week, KTV\>1.2
* capable of informed concent.
* rise in blood pressure during hemodialysis \> 10 mm Hg, for at least 50% of dialysis sessions in the month prior to inclusion.
* Normal volume status, by clinical physician assessment + bioimpedance

Exclusion Criteria

* age under 18,
* pregnancy
* unable to sign informed concent
* planned for kidney transplant in the following 3 month.
* congestive heart failure (NYHA 3-4)
* hospitalization for acute MI or CHF in the past 3 months.
* low compliece to medical therapy
* regular pre-dialysis tests with bicarbonate \> 24 in the past 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Shani Zilberman Itskovich

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shamir medical center

Ẕerifin, Is, Israel

Site Status

Countries

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Israel

Central Contacts

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Shani Zilberman Itskovich, Dr.

Role: CONTACT

+97289779383

Other Identifiers

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0208-25-ASF

Identifier Type: -

Identifier Source: org_study_id

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